EMA: Regulatory cooperation to improve global health

EMA experts meet with African regulators to discuss opportunities for collaboration. How to improve the availability of high quality, safe and effective medicines to patients in countries ...

EMA: Release of documents on two medicines temporarily halted

Release of documents on two medicines temporarily halted.
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...

FDA: Considerations in Demonstrating Interchangeability With a Reference Product

This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing ...

EMA: EMA encourages companies to submit Type I variations for 2016 by end of November

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to ...

RAPS: EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

The European Medicines Agency (EMA) released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across ...

EMA: Opening up clinical data on new medicines

EMA provides public access to clinical reports As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European ...

GMP: WHO publishes Second Draft of a Global Medical Devices Regulation

With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro ...

GMP: GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who ...

EMA: First comprehensive overview of global initiatives on medicine regulation published

The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the ...

EMA: Regulatory information – Updated SME user guide now available

The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. The guide aims to support SMEs to better ...